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A Study Explore JS001+JS002 in Patients With Advanced Cancer

NCT05128539 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-03-26

No results posted yet for this study

Summary

This open-label phase I clinical study with clinical development phase will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JS002 combined with Toripalimab in advanced cancer patients, who has failed standard therapy OR could not tolerate standard therapy OR refused/had no standard therapy.

This study is divided into two parts:

Part A. JS002 combined with Toripalimab dose escalation and dose expansion phase; Part B.JS002 combined with Toripalimab clinical expansion phase.

Conditions

Interventions

DRUG

JS001(Toripalimab)+JS002

Part A: In this phase, 3 dose levels will be preliminarily set up. The dose level of Toripalimab is fixed as 240 mg, intravenous infusion, Q3W. The dose levels of JS002 are fixed at 75 mg,150 mg and 300 mg subcutaneously, and the traditional 3+3 design will be used for dose escalation with 21 days as entire treatment cycle. In addition, the period of 21 days after the first administration is defined as the DLT observation period. Part B: Based on the data of the safety, PK and preliminary efficacy in Part A patients, the dosage will be determined for advanced tumor patients who had received at least first-line therapy in this part. Two to three groups with different tumor types will be further enrolled, and about 30 patients will be included in each group (the specific number and cohort will be adjusted according to the research progress). Toripalimab is a humanized IgG4κ mAb specific against human PD-1.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2023-11-10
Completion
2023-11-10

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05128539 on ClinicalTrials.gov